Diproderm 0.5 mg/g cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diproderm 0,5 mg/g cutaneous solution

Betamethasone dipropionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Diproderm 0,5 mg/g cutaneous solution is and what it is used for
2. What you need to know before using Diproderm 0,5 mg/g cutaneous solution
3. How to use Diproderm 0,5 mg/g cutaneous solution
4. Possible side effects
5. How to store Diproderm 0,5 mg/g cutaneous solution
6. Contents of the pack and other information

1. What Diproderm 0.5 mg/g Cutaneous Solution Is and What It Is Used For

Diproderm cutaneous solution is an anti-inflammatory medication (a corticosteroid) for topical use on the skin.

It is indicated for: Local treatment of inflammatory and pruritic (itchy) skin manifestations that respond to corticosteroids, such as: acute forms of allergy to a substance that has come into contact with the skin (allergic contact dermatitis), allergic reaction to substances commonly used, such as soap (irritant contact dermatitis), coin-shaped rash (nummular eczema), and itchy rash affecting the hands and feet (dyshidrotic eczema). Atopic dermatitis and neurodermatitis (rashes or eczemas related to patient-specific factors). Seborrheic dermatitis (skin eruption with inflammation and scaling), psoriasis (scaly red skin condition), exfoliative dermatitis (generalized red scaling), stasis dermatitis (skin inflammation near the ankles in venous insufficiency), lichen planus (itchy rash with bluish and white patches).

This medicine, in cutaneous solution form, is especially indicated for use on the scalp.

Diproderm 0.5 mg/g cutaneous solution is indicated in adults and children over 12 years of age.

2. What you need to know before using Diproderm 0.5 mg/g cutaneous solution

Do not use Diproderm 0.5 mg/g cutaneous solution

• if you are allergic to betamethasone (dipropionate), to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (for example: herpes or varicella)
• in areas of skin affected by skin inflammation with redness of the face (rosacea) or inflammation around the mouth (perioral dermatitis)
• in skin diseases associated with thinning of the skin (atrophy)
• in areas of skin showing a vaccination reaction, i.e. redness or inflammation after vaccination
• in the eyes or in deep wounds
• in children under 1 year of age
• if you have a fungal infection anywhere in your body.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Diproderm cutaneous solution.

• Anti-inflammatory drugs (corticosteroids), such as the active substance in Diproderm cutaneous solution, have significant effects on the body. The use of Diproderm cutaneous solution over large areas of the body or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.
• The medicine should not be applied under occlusive dressings (or air-impermeable materials, such as certain diapers).
• The medicine should not be applied to skin folds, such as the groin or armpits.
• It should not be applied to the face.
• If any hypersensitivity reaction occurs, treatment must be discontinued and appropriate therapy should be prescribed.
• If you develop an infection during treatment with this medicine, consult your doctor regarding treatment.
• Diproderm cutaneous solution must not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical application due to systemic absorption of the active substance, especially during treatment over large areas or for prolonged periods.
• If you use Diproderm cutaneous solution for conditions other than those for which it was prescribed, it may mask symptoms and complicate correct diagnosis and treatment.
• If you are being treated for psoriasis, your doctor should monitor your condition regularly to detect any possible worsening.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medicine is contraindicated in children under 1 year of age and is not indicated in children under 12 years of age.

In children, corticosteroids are more likely to pass through the skin into the body, increasing the risk of adverse effects in other parts of the body compared to adult patients.

In children treated with topical corticosteroids, adrenal gland dysfunction—glands located near the kidneys—has been reported, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), or increased pressure inside the skull (intracranial hypertension), which may manifest, among other signs, as bulging of the fontanelle in infants and headaches.

Use of Diproderm 0.5 mg/g cutaneous solution with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Diproderm 0.5 mg/g cutaneous solution and other medicines are known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

As a general rule, Diproderm cutaneous solution should not be used during the first trimester of pregnancy.

Diproderm cutaneous solution should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

Pregnant women or women planning to become pregnant should not use Diproderm cutaneous solution over large areas of skin, for prolonged periods, or under occlusive dressings.

Breastfeeding

Do not apply Diproderm cutaneous solution to the breasts during breastfeeding; avoid contact between the child and treated areas.

Do not use this medicine during breastfeeding unless directed by your doctor, and do not use it over large skin areas, for prolonged periods, or with occlusive dressings.

Driving and use of machines

Diproderm cutaneous solution does not affect the ability to drive or operate machinery.

3. How to use Diproderm 0.5 mg/g cutaneous solution

Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years of age:

Apply a few drops of the cutaneous solution to the affected area 1 or 2 times daily, in the morning and at night.

Your doctor will determine the frequency of application depending on the severity of the condition.

The duration of treatment should not exceed 2 weeks.

For topical use only.

The cutaneous solution should be applied with gentle massage, covering the affected area.

Use in children

Diproderm cutaneous solution is not indicated for children under 12 years of age and is contraindicated in children under 1 year of age.

If you use more Diproderm 0.5 mg/g cutaneous solution than you should

Excessive use of topical corticosteroids (repeated overdosing) may cause adverse effects (see section 4).

If you use the cutaneous solution more frequently than recommended or on large areas of skin, it may be absorbed into the body and cause various disorders; in children, this may affect their growth and development.

In cases of chronic toxicity, it is advisable to gradually withdraw corticosteroids.

Treatment of overdose is symptomatic. Acute symptoms due to excessive use of corticosteroids are generally reversible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service. Tel.: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Diproderm 0.5 mg/g cutaneous solution

Do not apply a double dose to make up for forgotten doses.

Apply the missed dose as soon as possible, then continue with your usual treatment schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported very rarely with the use of Diproderm 0.5 mg/g cutaneous solution: allergies and changes in skin color. With the use of the active substance in the medicine, irritation, and primarily burning and itching, may also occur.

The following reactions have additionally been reported with the use of topical corticosteroids, especially after prolonged application, on extensive areas, under dressings or occlusive materials, and/or in children:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Miliaria (red and white pimples in various parts of the body)
• Redness (erythema)
• Appearance of red spots
• Bruising
• Inflammation of hair follicles (folliculitis)
• Increased hair growth
• Skin striae (stretch marks)
• Acne
• Skin maceration
• Specific skin inflammation around the upper lip and chin (perioral dermatitis)
• Allergic skin reaction (contact dermatitis)
• Infections
• Hair loss
• Abnormal skin sensations, such as numbness, tingling, pricking, or burning of the skin (paresthesia)

Adverse effects may occur not only in the treated area but also in completely different parts of the body, which may happen if the active substance passes into the body through the skin.

This, for example, may increase eye pressure (glaucoma) or could cause a condition characterized by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased blood potassium levels, osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglycerides, increased blood and urine sugar levels (hyperglycemia and glucosuria), gastric ulcer, cataracts, and blurred vision with unknown frequency (frequency cannot be estimated from available data).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diproderm 0.5 mg/g cutaneous solution

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Diproderm 0.5 mg/g cutaneous solution after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diproderm 0,5 mg/g cutaneous solution

• The active substance is betamethasone (dipropionate).

Each gram (1.067 ml) of cutaneous solution contains 0.5 mg of betamethasone (0.05%).

(0.64 mg of betamethasone dipropionate).

• The other components (excipients) are carbomers, isopropyl alcohol, sodium hydroxide (pH adjustment) and purified water.

Appearance of the medicinal product and contents of the container

Diproderm 0,5 mg/g cutaneous solution is a colorless, viscous solution.

It is presented in a dropper container (bottle) containing 60 ml of cutaneous solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of the most recent revision of this leaflet: September 2017.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/